Protocol summary
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Study aim
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Determination of the success rate of free gingival graft treatment in increasing keratinized gingival width and vestibule depth with and without using periodontal dressing
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Design
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Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 26 patients. Randomization is done in a simple and individual way, and a table of random numbers is used for randomization.
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Settings and conduct
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The study is in the field of improving the quality of gingival tissue. Gingival transplant surgery will be performed for patients without sufficient keratinized gingiva in two groups, with and without using periodontal dressings, at Tehran Faculty of Dentistry. The researcher and the analyst are blinded to the study groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: people who have placed at least two implants at the posterior of the mandible due to partial edentulousness (as the most posterior teeth); Patient who have insufficient vestibular depth in this place.
Exclusion criteria: systemic disease that interferes with wound healing; alcohol and drug abuse; smoking; uncontrolled periodontal disease; pregnant and lactating mothers; patients with parafunctional habits.
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Intervention groups
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Intervention group: Free gingival graft surgery is performed in the edentulous area posterior of the mandible. The graft is harvested from the palate area. Finally, it is fixed in the intended place with stitches. Then, in patients, periodontal dressing is used in the place of fixation.
Control group: Free gingival graft surgery is performed in the edentulous area posterior of the mandible. The graft is harvested from the palate and fixed in the desired place with sutures.
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Main outcome variables
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The depth of the vestibule; Keratinized gingiva.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20231115060072N1
Registration date:
2023-12-12, 1402/09/21
Registration timing:
prospective
Last update:
2025-03-30, 1404/01/10
Update count:
1
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Registration date
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2023-12-12, 1402/09/21
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-04-08, 1403/01/20
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Expected recruitment end date
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2024-10-11, 1403/07/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparing the success rate of free gingival graft treatment with and without using periodontal dressing in increasing keratinized gingival width and vestibule depth: a randomized clinical trial
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Public title
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The success rate of gum grafting with and without dressing
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
People who have placed at least two implants at the posterior of mandible due to partial edentulousness (as the most posterior teeth).
Patients who have insufficient vestibular depth at the implants placement site.
Exclusion criteria:
Systemic disease that interferes with wound healing.
Alcohol and drug abuse
Cigarette smoking
Uncontrolled periodontal disease
Pregnant and lactating mothers
Patients with parafunctional habits
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
26
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple and individual randomization; People who meet the entry criteria are assigned a number and enter the study. Then, each number representing the patient is placed in one of the 2 intervention and control groups by the random number table. Sealed envelope method will be used for allocation concealment. Determining the placement of the dressing is written in the envelope for each patient, then on the day of the surgery, and at the end of that, the envelope for the patient is opened, and based on that, the dressing is placed or not at the surgery site.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The researcher and the statistical analyst are blinded to the type of surgical technique performed in each patient. The data in two groups A and B will be given to the analyzer without mentioning whether each group is a test or a control. There is no possibility of blinding the patients due to the observation of the dressing in the mouth. Also, until the end of the surgery and the placement of the dressing, the surgeon is unaware of which group the patient is in, so that the surgical procedure does not differ between the groups.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-11-15, 1402/08/24
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Ethics committee reference number
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IR.TUMS.DENTISTRY.REC.1402.081
Health conditions studied
1
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Description of health condition studied
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Gingival transplant surgery technique
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Vestibular depth
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Timepoint
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At the beginning of the study, 1 month after surgery, 3 months after surgery
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Method of measurement
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Intraoral scanner
2
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Description
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Keratinized gingiva
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Timepoint
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At the beginning of the study, 1 month after surgery, 3 months after surgery
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Method of measurement
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Periodontal probe
Intervention groups
1
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Description
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Intervention group:Free gingival graft surgery is performed in the edentulous area posterior of the mandible. The graft is harvested from the palate. Finally, it is fixed in the intended place with stitches. Then, in patients, periodontal dressing is used in the fixation place.
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Category
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Treatment - Surgery
2
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Description
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Control group: Free gingival graft surgery is performed in the edentulous area posterior of the mandible. After preparing the recipient bed, the graft is harvested from the palate. Finally, the grafted tissue is fixed in the intended place with sutures.
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Category
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Treatment - Surgery
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available